Clinics in Dermatology (2013) 31, 731–736

Dermal fillers: Facts and controversies

Uwe Wollina, MD, PhD a,⁎, Alberto Goldman, MD b
a
Department of Dermatology and Allergology, Academic Teaching Hospital Dresden-Friedrichstadt,
01067 Dresden, Germany
b
Clinica Goldman, Av. Augusto Meyer 163 conj. 1203, Porto Alegre RS, Brazil 90550–110

Abstract Dermal fillers have been used for decades in soft tissue augmentation. Currently, filler
implementation is among the most common minimally invasive procedures for rejuvenation and body
sculpturing. There is a broad variety of filler materials and products. Despite immense experience, a
number of controversies in this topic exist. Some of these controversies are addressed in this review, for
example, who should perform filler injections, the difference between permanent and nonpermanent
fillers, the off-label use of liquid silicone, and the role of pain reduction. Implementation of guidelines
and restriction of filler use by trained physicians can improve safety for patients.
© 2013 Elsevier Inc. All rights reserved.

Introduction uncontrolled or illegally. Some companies even sell dermal

The use of dermal fillers has become a cornerstone of
three-dimensional (3D) facial rejuvenation. The correct
placement of fillers can be done in an office-based setting
with almost no downtime, which is one of the reasons it is so
popular. The number of products is steadily growing; new
technical refinements such as injection techniques, needles,
and other medical devices have been developed. The classical
indications like nasolabial folds have expanded to the nose,
earlobes, décolleté, hands, and genitals1–4; nevertheless, there
are a number of controversies related to the use of fillers.
Dermal filler injection—It seems so easy
Very simply spoken, dermal filler injection is the
placement of foreign material under the skin. That seems
quite easy and is related to another issue: body modification
by tattooing and piercing. In many countries, beauticians and
other nonlicensed individuals are injecting dermal fillers,
fillers officially to beauticians. Many products of no-name
distributors have no licence at all. Internet sources are
available to everybody. This gray-black market poses a
major risk to patients.5
Dermal filler injection is not a cosmetic but a medical
procedure. It needs special skills and knowledge. The
procedure is safe in the hands of experienced physicians
but may be potentially harmful when skills and knowledge
are inappropriate, including vision loss, extensive skin
necrosis, or infection.6–11 A number of medical bodies
have developed guidelines for dermal filler use to ensure
basic knowledge, practical training, and recognition and
effective treatment of adverse effects.12–14 Such measures
help to minimize potential risks for patients.
Beauticians and other nonmedical professionals are not
the individuals to deal with medical problems. The use of
fillers (and the use of botulinum toxin) by nonmedical
professionals should be banned.
Permanent versus nonpermanent fillers

⁎ Corresponding author. Tel.: +49 351 480 1685; fax: +49 351 480 1219. Permanent fillers may be defined as using nonbiode-
E-mail address: wollina-uw@khdf.de (U. Wollina). gradable material that after injection will stay in the human

0738-081X/$ – see front matter © 2013 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.clindermatol.2013.05.010
732 U. Wollina, A. Goldman

experience of the physician, but also the area of injection.

The lips are prone to the highest number of adverse effects;
fortunately, most are temporary.11
Some authors concluded from their experience that
permanent fillers are not characterized by a higher rate of
foreign body granuloma formations than temporary im-
plants; however, if they occur, their clinical appearance is
more pronounced and their persistence longer if not treated
adequately (Figures 1–5).17
In a European survey, permanent fillers were responsible
for severe, persistent, and recurrent adverse effects.18 In the
German Injectable Filler Safety Study, adverse reactions to
nonpermanent fillers occurred after 4.9 ± 5.8 months and
reactions to permanent fillers after 18.3 ± 19.0 months.19 This
is important for follow-up of such patients. Too short a follow-
Fig. 1 Delayed persistence of redness and firm infiltration after up period will result in underreported adverse events. There is
permanent filler injection. another practical issue: If experts report on their practice, it will
reflect the best outcome in analogy to randomized clinical
trials. If registries report, they will provide a more realistic
body forever. It is neither digested nor used for tissue
regeneration. Such products may contain polymethyl
methacrylate microspheres, highly purified forms of liquid
silicone, and hydrogel polymers. 15,16 At first glance, the use
of permanent fillers is attractive—a single procedure and a
lifelong improvement.
Nonpermanent fillers are made of substances that occur in
the human body such as hyaluronic acid (HA), collagen, or
hydroxyl apatite. They will stay for a certain time, but
eventually the material is digested and metabolized. Multiple
procedures are necessary to enable a long-term result, which
does not seem too attractive.
When it comes to safety issues, there might be an
important difference between permanent and nonpermanent
products. Is the frequency of adverse effects after filler
implantation different between the two products? The rate of
adverse events after filler implantation ranges between
0.02% and 1%. This is clearly dependent on the skills and

Fig. 3 A 60-year-old woman with purulent infections and

Fig. 2 Soft subcutaneous nodule after hyaluronic acid filler drainage after hyaluronic acid injection. A, Initial presentation. B,
injection. The nodule resolved spontaneously within 2 weeks. After 2 weeks of antibiotic therapy and local care.
Dermal fillers: Facts and controversies 733

No silicone product for soft tissue augmentation has been

Fig. 4 A 75-year-old woman with chronic subcutaneous
nodules after polymethyl methacrylate microsphere injection
for hand rejuvenation.
approved by the U.S. Food and Drug Administration. The
major indication for U.S. Food and Drug Administration–
approved products is retinal detachment with removal of the
material after reattachment. In soft tissue augmentation,
removal of silicone is not performed. The use of liquid
silicon is off label.29
For decades, horrendous complications have been
reported from silicone injections into breasts, and its use
has been banned by many authorities. Here, both large-
volume implementation and multiple small depots were
used.29 Adverse effects have also been noted after use for
facial tissue augmentation.30–32 After illegal silicone injec-
tion, the silicone embolism syndrome has been observed
with potential fatal outcome in 24% of patients. Symptoms
and signs of the “silicone syndrome” include dyspnea, fever,
cough, hemoptysis, chest pain, hypoxia, alveolar hemor-
rhage, and altered consciousness.33

picture on adverse effects and patient safety including also the Hyaluronic acid or collagen?
less well trained and the less experienced, even the
nonlicensed, in analogy to post-marketing surveillance. Bovine collagen has been a hallmark for tissue augmen-
Registries can also make products safer, as shown for tation for decades.34 Collagen-based fillers have lost a lot of
poly-L-lactic acid, a semipermanent filler material. After
changing the treatment protocol using higher volumes for
reconstitution, the number of reported adverse events
decreased in Germany.20
Although experienced users are working with permanent
fillers without severe adverse effects or other problems, data
of registries of dermal filler complications speak another
language. The rate of severe complications and the need of
secondary surgery are increased by permanent fillers.18,21–23
This could be explained in part by a longer learning curve,
but host–filler reactions certainly are important as well. The
nonbiodegradable fillers are not inert as sometimes
claimed.23,24
There is a second issue, a biologic one. Smaller particles
are susceptible to phagocytosis. Although the larger particles
of permanent fillers do not change much over time, the
adjacent connective tissue does. This can result in filler
displacement over time and contradict the aesthetic im-
provement wanted.25

A word about liquid silicone

Silicone oils (liquid silicone) are more popular in the United
States and United Kingdom than in continental Europe. They
have been and are still used for soft tissue augmentation for a
broad range of indications.26 Proponents of silicone use argue
that large-volume injections, industrial-grade silicone, and
laypersons or unskilled medical staff are responsible for a
negative appearance of liquid silicone. Microdroplet technique Fig. 5 A 50-year-old woman with chronic inflammation,
and medical-grade silicone in the hand of the experienced user induration, and ulceration in the legs 2 years after polymethyl
are considered safe by some groups.27,28 methacrylate microsphere injections by a nonlicensed person.
734
market share by HA fillers, but are they really the less
convenient filler material?
The immediate clinical effects are comparable with recent
HA fillers tested in split-face trials, but long-term outcome
seems better with highly cross-linked HA gels.35,36 Colla-
gen, however, has a risk for delayed hypersensitivity
reactions in up to 5% of patients.37 Double skin testing
before treatment has been suggested to reduce the risk, but
even this cannot completely prevent hypersensitivity re-
actions. The maximum durability of collagen fillers has been
estimated at 9 months.34
The hyaluronic discourse: Monophasic
or biphasic
HA fillers have become the most popular dermal fillers of
the last decade. They consist of HA molecules of variable
length and cross-linking agents that affect the durability of
the product among other factors.
Clinical randomized controlled trials for the correction of
nasolabial folds observed comparable clinical efficacy and
durability of monophasic and biphasic fillers.38–41 Some
studies reported less severe side effects with a more rapid
resolution by monophasic HA.39,40
Histologic evaluation within 2 weeks after HA injection
demonstrated differences: Biphasic HA gel was found in big
depots, often deep in the reticular dermis. The depots
compressed collagen fibers. The papillary dermis and
superficial reticular dermis were free of HA. Monophasic
HA penetrated into the dermis in a diffuse, evenly distributed
manner, except in the papillary dermis, which remained free
of exogenous material.42 Other studies demonstrated that
most of the dermal HA fillers can be found in subcutaneous
layers.43
The data obtained so far provide some evidence for a
possibly better short-term safety profile of monophasic HA
gels, but more studies are needed.
No pain, no gain?
Pain and ecchymosis are the most common acute,
temporary adverse effects of dermal filler injection. The
use of topical anesthetics has not enough effect for deep filler
injection due to limited penetration.
Cooling before injection can reduce the immediate pain
by 61% and the ecchymosis by 88%. The effect is
measureable for at least 3 hours after the procedure.44
Another approach is mixing the HA gel with 2% lidocaine.
Professional products with incorporated lidocaine like
JUVÉDERM or PREVELLE Silk are on the market.
Comparative trials of HA gel with and without incorpo-
rated lidocaine suggested that patients rated the lidocaine-
HA gel injections more comfortable.45–47 This makes
U. Wollina, A. Goldman
sense in case of multiple injections because at least the
first injection on every side of the face will be the same
with both types of fillers. Slow injection speed is an
important measure to avoid adverse effects with or without
lidocaine. The risk of immunologically mediated adverse
reactions to lidocaine is low. 48
Do dermal fillers really improve
connective tissue?
The induction of neocollagenesis has become an idiom of
rejuvenation. The claims in advertisement associate almost
every product with improved collagen production. The
proof, however, is scarce.
Poly-L-lactic acid stimulates in vitro fibroblasts. 49
Histologic studies in 10 patients with HIV-related facial
lipodystrophy demonstrated a foreign body reaction with
multinucleated giant cells with phagocytized lactate crystals.
New collagen formation was demonstrated.50
In vitro non–cross-linked HA stimulates fibroblast
activity, but not migration.51 Non–cross-linked HA is not
used as dermal filler due to the short half-life.3
Researchers analyzed forearm skin biopsies in 11 human
volunteers with sun-damaged skin after injection of cross-
linked HA.52 Immunostaining in skin receiving cross-
linked HA injections revealed increased collagen deposition
around the filler. Staining for prolyl-4-hydroxylase and the
C- and N-terminal epitopes of type I procollagen was
enhanced up to 13 weeks after treatment. Gene expression
for types I and III procollagen, as well as several profibrotic
growth factors, were also up-regulated up to 13 weeks
compared with controls. Fibroblasts in filler-injected skin
demonstrated a mechanically stretched appearance and a
biosynthetic phenotype. In vitro, fibroblasts did not bind
the filler, suggesting that cross-linked HA is not directly
stimulatory but the mechanical stress elucidated by
implementation of the gel.52 The data may suggest that
there should be a different fibroblast response between
larger depots and microdroplet injections, but this has not
been studied in detail.
Repeated facial injection of cross-linked HA over time
produces a surplus of connective tissue as shown by decreased
expenditure to achieve the same volumizing effect.53
Particulated (polymethyl methacrylate) fillers (like Artefill)
are inducing a granulomatous foreign body reaction around
microspheres.24 Calcium hydroxylapatite microspheres (like
Radiesse) might induce a similar body reaction. This has led to
the definition of no-go areas for facial treatment with this filler
type, that is, areas with pronounced motion such as perioral or
periocular skin. In accordance with the specific treatment
guidelines, calcium hydroxylapatite exerts safe and long-term
effects.15,54,55 Skin necrosis, however, has also been observed
with calcium hydroxylapatite.56
Particulated filler exerts a stimulation of markers of
monocyte/macrophage activation (innate immunity). Analysis
Dermal fillers: Facts and controversies
by filler type showed subjects injected with calcium
hydroxylapatite, methacrylate, acrylamides, and silicone to
have values significantly greater than those of nonfiller
subjects, probably because these filler materials are stable
over longer periods. By contrast, HA alone elicited little
immune response.57
The available data demonstrate that every filler type
induces a certain body reaction after implementation. The
type and amount of tissue reaction, however, is not uniform.
Some filler induces a longer lasting host reaction. This type
might be called biostimulatory but bears a potential risk of
delayed adverse reactions.
Conclusions
Although dermal fillers have been used for decades in
aesthetic medicine, the ideal filler is still not available.
Patients’ safety is hampered by nonlicensed products and
users. Follow-up of patients by trained physicians is
necessary to reduce risks and initiate early treatment in
case of complications.
In the future, individualized, specifically tailored filler
might become available. Today, careful selection of
patients and particular selection of products, matching
particular needs, is the best way to perform safe three-
dimensional rejuvenation.
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